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FDA 510(k)

BIOGRAM

K-Number: K843725 · 1985-05-21

ApplicantGiles Scientific, Inc.
Decision Date1985-05-21
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Giles Scientific, Inc.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K843725. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGRAM?

BIOGRAM is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Giles Scientific, Inc.. The 510(k) number is K843725.

When did BIOGRAM receive FDA 510(k) clearance?

BIOGRAM received FDA 510(k) clearance on 1985-05-21, under 510(k) number K843725.

Who is the listed applicant for BIOGRAM?

The FDA 510(k) record lists Giles Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGRAM?

The FDA product code for BIOGRAM is JTN.

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Other records listing Giles Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944319BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEMK932122BIOMIC VIDEO PLATE READERK854521BIOGRAM

Related Devices (Code: JTN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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